Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

NCT ID: NCT00558259

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

Brief Summary

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

dabigatran etexilate 150 mg BID

Patient to receive dabigatran etexilatate capsules 150 mg twice daily

Group Type: EXPERIMENTAL

dabigatran etexilate 150 mg twice daily (BID)

Intervention Type: DRUG

dabigatran etexilate capsules 150 mg BID

matching placebo twice daily (BID)

Patient to receive dabigatran extexilate matching placebo capsules twice daily

Group Type: PLACEBO_COMPARATOR

matching placebo twice daily (BID)

Intervention Type: DRUG

Matching placebo BID

Interventions

dabigatran etexilate 150 mg twice daily (BID)

dabigatran etexilate capsules 150 mg BID

Intervention Type: DRUG

matching placebo twice daily (BID)

Matching placebo BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.

2. Written informed consent

Exclusion Criteria

1. Younger then 18 years of age

2. Indication for VKA other than DVT and/or PE

3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued

4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN

5. Creatinine clearance < 30 ml/min

6. Acute bacterial endocarditis

7. Active bleeding or high risk for bleeding.

8. Uncontrolled hypertension (investigators judgement)

9. Intake of another experimental drug within the 30 days prior to randomization into the study

10. Life expectancy <6 months

11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1160.63.01025 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1160.63.01023 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

1160.63.01002 Boehringer Ingelheim Investigational Site

Laguna Hills, California, United States

1160.63.01014 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

1160.63.01003 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

1160.63.01030 Boehringer Ingelheim Investigational Site

Key West, Florida, United States

1160.63.01022 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

1160.63.01044 Boehringer Ingelheim Investigational Site

New Iberia, Louisiana, United States

1160.63.01017 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

1160.63.01004 Boehringer Ingelheim Investigational Site

Salisbury, Maryland, United States

1160.63.01016 Boehringer Ingelheim Investigational Site

Worcester, Massachusetts, United States

1160.63.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1160.63.01019 Boehringer Ingelheim Investigational Site

Missoula, Montana, United States

1160.63.01032 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

1160.63.01001 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

1160.63.01024 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

1160.63.01005 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

1160.63.01020 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

1160.63.01011 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

1160.63.01007 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

1160.63.01035 Boehringer Ingelheim Investigational Site

Bellevue, Washington, United States

1160.63.61002 Boehringer Ingelheim Investigational Site

Greenslopes, Queensland, Australia

1160.63.61003 Boehringer Ingelheim Investigational Site

Elizabeth Vale, South Australia, Australia

1160.63.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

1160.63.61004 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

1160.63.43005 Boehringer Ingelheim Investigational Site

Graz, , Austria

1160.63.43006 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

1160.63.43001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1160.63.43002 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1160.63.43004 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1160.63.32005 Boehringer Ingelheim Investigational Site

Aalst, , Belgium

1160.63.32004 Boehringer Ingelheim Investigational Site

Duffel, , Belgium

1160.63.32003 Boehringer Ingelheim Investigational Site

Kortrijk, , Belgium

1160.63.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1160.63.32002 Boehringer Ingelheim Investigational Site

Lier, , Belgium

1160.63.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

1160.63.02004 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

1160.63.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1160.63.02020 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

1160.63.42004 Boehringer Ingelheim Investigational Site

České Budějovice, , Czechia

1160.63.42003 Boehringer Ingelheim Investigational Site

Jablonec nad Nisou, , Czechia

1160.63.42008 Boehringer Ingelheim Investigational Site

Kladno, , Czechia

1160.63.42012 Boehringer Ingelheim Investigational Site

Liberec, , Czechia

1160.63.42010 Boehringer Ingelheim Investigational Site

Nymburk, , Czechia

1160.63.42009 Boehringer Ingelheim Investigational Site

Ostrava, , Czechia

1160.63.42011 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, , Czechia

1160.63.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1160.63.42006 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1160.63.42002 Boehringer Ingelheim Investigational Site

Prague 4-Krc, , Czechia

1160.63.42005 Boehringer Ingelheim Investigational Site

Prostějov, , Czechia

1160.63.42007 Boehringer Ingelheim Investigational Site

Rakovník, , Czechia

1160.63.42013 Boehringer Ingelheim Investigational Site

Slaný, , Czechia

1160.63.42014 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

1160.63.37202 Boehringer Ingelheim Investigational Site

Kohtla-Järve, , Estonia

1160.63.37203 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

1160.63.37201 Boehringer Ingelheim Investigational Site

Tartu, , Estonia

1160.63.49013 Boehringer Ingelheim Investigational Site

Darmstadt, , Germany

1160.63.49017 Boehringer Ingelheim Investigational Site

Dresden, , Germany

1160.63.49018 Boehringer Ingelheim Investigational Site

Dresden, , Germany

1160.63.49014 Boehringer Ingelheim Investigational Site

Giessen, , Germany

1160.63.49011 Boehringer Ingelheim Investigational Site

Ludwigshafen, , Germany

1160.63.49005 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

1160.63.49010 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

1160.63.49007 Boehringer Ingelheim Investigational Site

München, , Germany

1160.63.49009 Boehringer Ingelheim Investigational Site

Püttlingen, , Germany

1160.63.39006 Boehringer Ingelheim Investigational Site

Bergamo, , Italy

1160.63.39015 Boehringer Ingelheim Investigational Site

Castelfranco Veneto (TV), , Italy

1160.63.39019 Boehringer Ingelheim Investigational Site

Chieti Scalo (CH), , Italy

1160.63.39003 Boehringer Ingelheim Investigational Site

Cosenza, , Italy

1160.63.39008 Boehringer Ingelheim Investigational Site

Fidenza (PR), , Italy

1160.63.39011 Boehringer Ingelheim Investigational Site

Florence, , Italy

1160.63.39009 Boehringer Ingelheim Investigational Site

Genova, , Italy

1160.63.39004 Boehringer Ingelheim Investigational Site

Milan, , Italy

1160.63.39010 Boehringer Ingelheim Investigational Site

Milan, , Italy

1160.63.39020 Boehringer Ingelheim Investigational Site

Milan, , Italy

1160.63.39022 Boehringer Ingelheim Investigational Site

Napoli, , Italy

1160.63.39001 Boehringer Ingelheim Investigational Site

Palermo, , Italy

1160.63.39007 Boehringer Ingelheim Investigational Site

Pisa, , Italy

1160.63.39012 Boehringer Ingelheim Investigational Site

Rimini, , Italy

1160.63.39017 Boehringer Ingelheim Investigational Site

Roma, , Italy

1160.63.39014 Boehringer Ingelheim Investigational Site

Treviso, , Italy

1160.63.39002 Boehringer Ingelheim Investigational Site

Udine, , Italy

1160.63.39016 Boehringer Ingelheim Investigational Site

Vittorio Veneto (TV), , Italy

1160.63.37101 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

1160.63.37102 Boehringer Ingelheim Investigational Site

Riga, , Latvia

1160.63.37002 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

1160.63.37001 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

1160.63.31010 Boehringer Ingelheim Investigational Site

Assen, , Netherlands

1160.63.31006 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

1160.63.31011 Boehringer Ingelheim Investigational Site

Den Helder, , Netherlands

1160.63.31012 Boehringer Ingelheim Investigational Site

Dirksland, , Netherlands

1160.63.31003 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

1160.63.31001 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

1160.63.31009 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

1160.63.31008 Boehringer Ingelheim Investigational Site

Oss, , Netherlands

1160.63.31007 Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

1160.63.64002 Boehringer Ingelheim Investigational Site

Christchurch, , New Zealand

1160.63.48010 Boehringer Ingelheim Investigational Site

Kielce, , Poland

1160.63.48003 Boehringer Ingelheim Investigational Site

Poznan, , Poland

1160.63.48001 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.48002 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.48004 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.48005 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.48006 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.48007 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.48008 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1160.63.07004 Boehringer Ingelheim Investigational Site

Kursk, , Russia

1160.63.07014 Boehringer Ingelheim Investigational Site

Ufa, , Russia

1160.63.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

1160.63.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

1160.63.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, , Russia

1160.63.65001 Boehringer Ingelheim Investigational Site

Singapore, , Singapore

1160.63.27003 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

1160.63.27007 Boehringer Ingelheim Investigational Site

Centurion, , South Africa

1160.63.27009 Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

1160.63.27001 Boehringer Ingelheim Investigational Site

Somerset West, , South Africa

1160.63.82010 Boehringer Ingelheim Investigational Site

Gwangju, , South Korea

1160.63.82003 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

1160.63.82005 Boehringer Ingelheim Investigational Site

Kyeonggi-do, , South Korea

1160.63.82001 Boehringer Ingelheim Investigational Site

Kyunggi-do, , South Korea

1160.63.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1160.63.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1160.63.82008 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1160.63.82011 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1160.63.82007 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

1160.63.46001 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

1160.63.46006 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

1160.63.46002 Boehringer Ingelheim Investigational Site

Lund, , Sweden

1160.63.46004 Boehringer Ingelheim Investigational Site

Mölndal, , Sweden

1160.63.46007 Boehringer Ingelheim Investigational Site

Skövde, , Sweden

1160.63.46005 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

1160.63.46003 Boehringer Ingelheim Investigational Site

Värnamo, , Sweden

1160.63.41012 Boehringer Ingelheim Investigational Site

Basel, , Switzerland

1160.63.41011 Boehringer Ingelheim Investigational Site

Bruderholz, , Switzerland

1160.63.41003 Boehringer Ingelheim Investigational Site

Cham, , Switzerland

1160.63.41001 Boehringer Ingelheim Investigational Site

Glarus, , Switzerland

1160.63.41014 Boehringer Ingelheim Investigational Site

Lucerne, , Switzerland

1160.63.41016 Boehringer Ingelheim Investigational Site

Lucerne, , Switzerland

1160.63.41005 Boehringer Ingelheim Investigational Site

Schiers, , Switzerland

1160.63.41009 Boehringer Ingelheim Investigational Site

Thun, , Switzerland

1160.63.41022 Boehringer Ingelheim Investigational Site

Wetzikon, , Switzerland

1160.63.41008 Boehringer Ingelheim Investigational Site

Zug, , Switzerland

1160.63.41006 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

1160.63.66002 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

1160.63.66003 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

1160.63.66004 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

1160.63.66001 Boehringer Ingelheim Investigational Site

Chiang Mai, , Thailand

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; Estonia; Germany; Italy; Latvia; Lithuania; Netherlands; New Zealand; Poland; Russia; Singapore; South Africa; South Korea; Sweden; Switzerland; Thailand

References

Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

Reference Type: DERIVED

PMID: 24081972 (View on PubMed)

Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.

Reference Type: DERIVED

PMID: 23425163 (View on PubMed)

Other Identifiers

2007-002586-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.63

Identifier Type: -

Identifier Source: org_study_id